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Device

HD-tDCS + mCILT for Primary Progressive Aphasia

Phase 2

Waitlist Available

Led By Roy H Hamilton, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be able to understand the nature of the study, and give informed consent

Native English speaker

Must not have

Small vessel disease

Presence of additional neurological illness such as stroke or traumatic brain injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks

Summary

This trial is testing whether high-definition transcranial direct current stimulation (HD-tDCS) paired with modified constraint-induced language therapy (mCILT) can improve language performance in people with primary progressive aphasia (PPA). The study will compare changes in language performance and brain imaging before and after receiving 10 semi-consecutive daily sessions of real or sham HD-tDCS + mCILT. The 3-month follow-up will be the primary endpoint.

Who is the study for?

This trial is for native English speakers who can understand the study and consent to participate, diagnosed with nonfluent agrammatic PPA or logopenic variant PPA, and have at least a high school education. It's not for those with skull breaches, other neurological issues like stroke or brain injury, epilepsy/seizures history, pacemakers/ICDs, or small vessel disease.

What is being tested?

The study tests if language therapy combined with electrical brain stimulation (HD-tDCS) improves language in people with certain types of aphasia. Participants receive real or fake treatments over 10 days and are assessed immediately after and again three months later to see which works better.

What are the potential side effects?

Possible side effects from HD-tDCS may include discomfort at the electrode site on the head, itching, tingling during stimulation sessions, headache, fatigue. These are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study and can give my consent.

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I am a native English speaker.

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I have been diagnosed with a specific type of language disorder due to PPA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have small vessel disease.

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I have had a stroke or traumatic brain injury.

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I have had surgery on my skull.

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I have been diagnosed with epilepsy or have recurring seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aphasia

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: HD-tDCS+mCILTActive Control2 Interventions

Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of HD-tDCS for 20 minutes using a montage in which a central electrode (1.5mA) is placed over the left frontotemporal area and four surrounding cathodes (.375mA each). Subjects will participate in a modified constraint-induced language therapy.

Group II: Sham+mCILTPlacebo Group2 Interventions

Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham for 20 minutes using a montage in which a central electrode is placed over the left frontotemporal area and four surrounding cathodes. Subjects will participate in a modified constraint-induced language therapy,

0 / 7Eligibility criteria met